Pharmacy Daily | Alphapharm valsartan recall

ALPHAPHARM, trading as Mylan Australia, has initiated a nationwide consumer-level recall of all batches of its Dilart and Dilart HCT valsartan medicines in Australia.

The move follows action last week (PD 22 Nov), where the European Medicines Agency banned valsartan made by Mylan in India after the discovery of N-nitrosodiethylamine (NDEA) in some batches.

NDEA is classified as a probable human carcinogen, with Mylan saying "the estimated risk from use of these tablets is very low".

The recall applies to all batches of Dilart and Dilart HCT, in all strengths, distributed between Aug 2016 and Nov 2018.

Patients are being asked to return any of the medications to the supplying pharmacy for a refund and to discuss replacement options.

Valsartan (Dilart) is used for the treatment of hypertension, for the treatment of heart failure in patients receiving usual therapy who are intolerant to ACE inhibitors, and to reduce cardiovascular mortality following a heart attack.

Valsartan in combination with hydrochlorothiazide (Dilart HCT) is used to control hypertension.

Alphapharm said patients who were on these medications should not stop taking them before consulting a health care professional, as the risk of harm to health may be higher if treatment is stopped immediately.

Mylan is also recalling 15 lots of valsartan-containing products in the USA, with the Food and Drug Administration saying it continues to investigate and test all angiotensin II receptor blockers (ARBs) for the presence of NDEA and N-nitrosodimethylamine (NDMA) above acceptable levels.

Some Chinese ingredient manufacturers have also had valsartan products recalled earlier this year (PD 11 Jul, PD 09 Aug) but at the time the TGA said no Australian items were affected.